Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study (NCT03186404) | Clinical Trial Compass
UnknownPhase 2
Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study
Canada112 participantsStarted 2018-05-10
Plain-language summary
Anthracycline (AC) chemotherapy has substantially reduced the mortality rate from several common cancers globally. Unfortunately, AC treatment is associated with up to 19% risk of heart failure (HF). Current standard of care for preventing AC induced HF (AIHF) is cardiac surveillance followed by initiation of treatment once HF is diagnosed. With this approach 89% of patients fail to recover heart function and 46% will experience adverse cardiac events. Therefore there is a need for effective preventive therapy to reduce the risk of AIHF. Based on small human studies, animal studies, and our own pilot data, statins are an ideal class of drug for this purpose.
We will conduct a pilot double blinded, placebo controlled, randomized controlled trial to assess whether pre-treatment with statins before AC can prevent heart dysfunction. Eligible patients with cardiovascular risk factors scheduled to receive AC will be recruited. They will be randomized to statin therapy or placebo and followed until the end of cancer treatment. Primary outcome is the difference in cardiac MRI-determined left ventricular ejection fraction between pre-AC and end of treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with one of the following malignancies requiring anthracycline based chemotherapy with a curative intent: breast cancer; aggressive lymphomas; leukemia (acute myelogenous leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or; sarcoma
✓. Patients with high cardiovascular risk defined as:
✓. Living within geographic area conducive to repeated clinical and imaging follow-up
Exclusion criteria
✕. Participating in another clinical research study where randomization would be unacceptable
✕. Previous history of statin intolerance
✕. Already on statin therapy or known statin indicated condition:
✕. CK level \>3x upper limit of normal
✕. Evidence of hepatic dysfunction (ALT level \>2x upper limit of normal)
✕. On a drug that is a strong inhibitor of cytochrome P450 3A4 or may require such treatment during the treatment period (because atorvastatin is metabolized by this pathway)
What they're measuring
1
Cardiac MRI measured LVEF within 4 weeks of anthracycline completion
Timeframe: Within 4 weeks of cancer therapy completion